Study of Myopia Prevention in Children With Low Concentration of Atropine
Information source: Min-Sheng General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myopia
Intervention: atropine (Drug); tropicamide (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Min-Sheng General Hospital Official(s) and/or principal investigator(s): Leon Chih-Kai Liang, MD MMS, Principal Investigator, Affiliation: Min-Sheng General Hospital; National Yang-Ming university, Taiwan
Overall contact: Leon Chih-Kai Liang, MD MMS, Phone: 03-3179599, Ext: 8333, Email: eye.care@msa.hinet.net
Summary
The purpose of this study is to test the hypothesis that myopia can be prevented by using a
low concentration of atropine eyedrops once a week.
Clinical Details
Official title: Pilot Study of Prevention Myopia in Children With Low Concentration of Atropine
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: cycloplegic refraction, visual acuity
Secondary outcome: axial length
Detailed description:
The prevalence rate of myopia is rising rapidly in several Asian countries. A prevalence
survey conducted in 1995 of 11178 school children in Taiwan were 12 percent for six year old
and 84 percent for teenagers 16 o 18 years. Among them, twenty percent were high myopes.
While in the United States and Europe the prevalence rate in older adults is 20% to 50%. The
rate of progression of myopia is highest in young children, and the average age of
stabilization of myopia is approximately 16 years. The onset of myopia may occur at a
relatively young age, leading to higher risks of high myopia (myopia at least 6. 0 diopters )
in adulthood. High myopia is associated with potentially blinding complications. Therefore,
prevention of myopia progression is important in Taiwan, especially in young children.
There is some evidence that atropine eyedrops retard myopia progression in three randomized
clinical trials. It is believed that atropine act on muscarinic receptor located in the
sclera and through some unknown mechanism retard the elongation rate of axial length.
However, the possible long-term side effects such as cataract formation and retinal
toxicity, are largely unknown. Photophobia in daily life, accommodation difficulty both
decrease the acceptance of atropine usage and compliance.
There are some evidence that the rate of axial elongation of eyeball are different between
pre-myopic stage and myopic stage. Therefore, if we can use low concentration of atropine
eyedrops before myopia development. Maybe we can prevent abnormal axial length elongation
with lower dosage of atropine eyedrops compared with daily use of atropine eyedrops in true
myopia stage.
Clinical study was conducted by randomized control trial. 60 school-aged children were
recruited ( Age 7 to 12 years ). All with pre-myopia ( spherical equivalent between +0. 50
and - 0. 75 ) after cycloplegic refraction. Visual acuity of naked eyes are above 0. 6. None of
them had tropia, amblyopia, eyelid disease, ocular problems. The astigmatism was less than
- 1. 0D and anisometropia was less than 1. 0D. The children were randomly assigned into two
groups by using randomized consent design. The first group use 0. 25% atropine once a week.
The second group keep traditional treatment using 0. 5% tropicamide eyedrop every day. All
children had complete ophthalmologic examination before enrollment. Follow-up examinations
were performed every 3 months for 12 months duration. These examinations included visual
acuity of naked eye. Intraocular pressure, refractive status. The cycloplegic refraction and
axial length were measured every 6 months.
Eligibility
Minimum age: 7 Years.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Aged 7 to 12 years old
- Has pre-myopia (spherical equivalent between +0. 50 and -0. 75) after cycloplegic
refraction.
- Visual acuity of naked eyes are above 0. 6.
- Astigmatism is less than -1. 0D and anisometropia less than 1. 0D.
Exclusion Criteria:
- Has tropia, amblyopia, eyelid disease, or ocular problems.
Locations and Contacts
Leon Chih-Kai Liang, MD MMS, Phone: 03-3179599, Ext: 8333, Email: eye.care@msa.hinet.net
Min-Sheng General Hospital, Tao-Yuan, Taiwan; Recruiting
Additional Information
Starting date: April 2007
Last updated: October 9, 2007
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